Approval for Hypertension Polypill

The US Food and Drug Administration (FDA) has approved a polypill for hypertension, a combination of perindopril arginine and amlodipine (Prestalia/ Symplmed Pharma-Servier).

The approval was based on data from a trial involving 837 patients. The study showed that a fixed-dose combination of the two drugs in a single pill “was significantly better than either compound alone in reducing both sitting diastolic and sitting systolic blood pressure after six weeks of treatment,” the company announced.

Other studies have shown that using these drugs together may reduce cardiovascular events.

George Bakris, MD, principal investigator in the trial of the drug, known as PATH, called Prestalia “another great combination of two drugs each with an evidence based outcome history.”

The drug combines perindopril arginine, and angiotensin converting enzyme inhibitor and amlodipine, a calcium channel blocker. It is meant to treat hypertension and may be used in patients whose blood pressure is not adequately control on monotherapy. By lowering blood pressure, the risk of cardiovascular events is reduced. But the company said there are no controlled trials demonstration the degree of that risk reduction.

Prestalia is contraindicated in patients with hereditary or idiopathic angioedema, with or without previous ACE inhibitor treatment. The drug should be immediately discontinued should a patient’s pregnancy be discovered. It is toxic to the developing fetus and can result in fetal injury or death.